Obstructive Sleep Apnea Syndrome (OSA) and Getemed (GETEMED)
It is often clinically impossible to differentiate children with an isolated snoring from those with OSA. The diagnosis of OSA is currently based on nocturnal, laboratory-based polysomnography. This expensive examination is poorly accessible due to appointments delays at hospital.
Our study is designed to compare the characteristics of a home polysomnography versus standard polysomnography for the diagnosis of pediatric OSA.
|Sleep Apnea, Obstructive||Device: home polysomnography (GETEMED) Device: standard polysomnography (BRAINNET II)|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Diagnostic Characteristics of a Home Polysomnograph for the Diagnosis of Patients With Obstructive Sleep Apnea Syndrome - A Pilot Study|
- Characteristics of a home polysomnograph versus standard polysomnography for the diagnosis of OSA in children. [ Time Frame: 1 night ]
- Standard polysomnography considered pathological if obstructive apnea-hypopnea index (AHI) > 5 / hr.
Home polysomnography considered pathological if at least one of the following criteria is present :
- Respiratory Disturbance Index (RDI) > 10 / hr + /- Desaturation Index > 4% for more than 2.5 / hr.
- Brouillette index ; pulse wave > 3 desaturation clusters and > 3 desaturation <90%.
- To determine polygraphic pathological criteria by comparing the RDI per hour of the home polysomnography versus the (AHI) of the standard polysomnography. [ Time Frame: 1 night ]
|Study Start Date:||October 2012|
|Study Completion Date:||January 2016|
|Primary Completion Date:||January 2016 (Final data collection date for primary outcome measure)|
Experimental: home polysomnography and standard polysomnography
home polysomnography (GETEMED) and standard polysomnography (BRAINNETII) are both carried out in children during 1 night.
Device: home polysomnography (GETEMED)
Other Name: GETEMEDDevice: standard polysomnography (BRAINNET II)
Other Name: BRAINNET II
Please refer to this study by its ClinicalTrials.gov identifier: NCT01720823
|Hospices Civils de Lyon- Hôpital Femme Mère Enfant|
|Bron, France, 69677|
|Principal Investigator:||Patricia FRANCO, MD||Hospices Civils de Lyon- Hôpital Femme Mère Enfant|